The following data is part of a premarket notification filed by 3d Industrial Imaging Co.,ltd. with the FDA for Dentiq3d.
| Device ID | K160666 |
| 510k Number | K160666 |
| Device Name: | Dentiq3D |
| Classification | System, Image Processing, Radiological |
| Applicant | 3D INDUSTRIAL IMAGING CO.,LTD. 413 Institute Of Computer Technology Seoul National University, Daehak-dong, Gwanak-gu, KR |
| Contact | Jin Sa Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 110 Irvine, CA 92620 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-09 |
| Decision Date | 2016-10-05 |
| Summary: | summary |